Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

NCT02732015 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0587NCI-2016-00801
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

Conditions

Locally Advanced Sarcoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose

  Complete response (CR) no emetic episodes and no rescue medications.

  Days 1-10

Study Arms (2)

Arm I (rolapitant hydrochloride)

EXPERIMENTAL

Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Drug: Dexamethasone; Drug: Doxorubicin; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Mesna; Drug: Ondansetron; Other: Questionnaire Administration; Drug: Rolapitant Hydrochloride; Drug: Vincristine Sulfate

Arm II (fosaprepitant dimeglumine)

ACTIVE COMPARATOR

Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.

Drug: Dexamethasone; Drug: Doxorubicin; Drug: Fosaprepitant Dimeglumine; Drug: Ifosfamide; Other: Laboratory Biomarker Analysis; Drug: Mesna; Drug: Ondansetron; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Interventions

Dexamethasone DRUG

Given IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Doxorubicin DRUG

Given IV

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Fosaprepitant Dimeglumine DRUG

Given IV

Also known as: Emend for Injection, L-785,298, MK-0517

Arm II (fosaprepitant dimeglumine)

Ifosfamide DRUG

Given IV

Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Mesna DRUG

Given IV

Also known as: 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna, Mercaptoethane Sulfonate, Mercaptoethanesulfonate, Mesnex, Mesnil, Mesnum, Mexan, Mistabron, Mistabronco, Mitexan, Mucofluid, Mucolene, UCB 3983, Uromitexan, Ziken

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Ondansetron DRUG

Given IV

Also known as: Zofran ODT, Zuplenz

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Questionnaire Administration OTHER

Ancillary studies

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Rolapitant Hydrochloride DRUG

Given PO

Also known as: Rolapitant HCl, Rolapitant Hydrochloride Monohydrate, Rolapitant Monohydrochloride Monohydrate, SCH-619734, SCH619734, Varubi

Arm I (rolapitant hydrochloride)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Arm I (rolapitant hydrochloride); Arm II (fosaprepitant dimeglumine)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated
• Patient must have an estimated life expectancy \>= 4 months in the opinion of the investigators
• Male and females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD) or abstinence
• Female patients must have a negative pregnancy test at screening
• Female patients of childbearing potential must agree to use an acceptable method of birth control (excluding hormonal birth control methods) for 72 hours prior to admission and to continue its use during the study and for at least 30 days after the final dose
• Male patients must agree to use an acceptable form of birth control from study day 1 through at least 30 days after the final dose
• Absolute neutrophil count (ANC) \> 1500/mm\^3
• Platelet count \> 100,000/mm\^3
• Serum creatinine \< 1.5 mg/dL
• Serum bilirubin count \< 1.5 x upper limit normal (ULN)
• Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \< 2.5 x ULN; for subjects with known liver metastases \< 5 x ULN
• Karnofsky performance status \> 60%
• Signed informed consent form
• Patients are required to read and understand English to comply with protocol requirements

You may not qualify if:

• Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
• Patient has a known hypersensitivity to the administration of any prescribed oral or intravenous study medication or metabolite, including but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection
• Patient is a woman with a positive urine or serum pregnancy test within 3 days prior to study drug administration, is breast-feeding, or is planning to conceive children within the projected duration of the study treatment
• Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug:
• hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product
• Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.)
• Benzamides (metoclopramide, alizapride, etc.)
• Domperidone
• Cannabinoids
• Neurokinin (NK)1 antagonist (aprepitant)
• Benzodiazepines (lorazepam, alprazolam, etc)
• Herbal medications or preparations in doses designed to ameliorate nausea or emesis
• Patient has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of day 1 of the study except as premedication for chemotherapy (e.g., taxanes); subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled
• Patient has symptomatic primary or metastatic central nervous system (CNS) disease
• Patient has ongoing vomiting, retching, dry heaves, or clinically significant nausea caused by any etiology, or has had such symptoms within 24 hours prior to the start of day 1 of the study intervention, or has a history of anticipatory nausea and vomiting

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Doxorubicin; fosaprepitant; Aprepitant; Ifosfamide; Mesna; Ondansetron; rolapitant; Vincristine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indolizidines; Indolizines

Results Point of Contact

• Title: Saroj Vadhan,MD-Clinical Professor, Cytokine & Supportive Oncology
• Organization: UT MD Anderson Cancer Center

svadhanr@mdanderson.org

713-792-7966

Study Officials

• Saroj Vadhan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 8, 2016
• Study Start: October 12, 2016
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: August 9, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-08

Locations

US (1)